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Prospective Evaluation of Hypofractionation Proton Beam Therapy With Concurrent Treatment of the Prostate and Pelvic Nodes for Clinically Localized, High Risk or Unfavorable Intermediate Risk Prostate Cancer

This study is currently recruiting participants.
Verified May 2017 by Chunhee Richard Choo, M.D., Mayo Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT02874014
First Posted: August 22, 2016
Last Update Posted: May 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Chunhee Richard Choo, M.D., Mayo Clinic
  Purpose
The study is to examine a moderate hypofractionation regimen of proton beam therapy for high risk or unfavorable intermediate risk prostate cancer. The prostate and seminal vesicles are treated with 6750 centigray (RBE) in 25 fractions (i.e. 270 centigray/fraction), while the regional pelvic nodes receive 4500 centigray (RBE) in 25 fractions (i.e. 180 centigray/fraction) simultaneously. The overall treatment time is 5 weeks.

Condition Intervention
Prostate Cancer Radiation: Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Hypofractionation Proton Beam Therapy With Concurrent Treatment of the Prostate and Pelvic Nodes for Clinically Localized, High Risk or Unfavorable Intermediate Risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Chunhee Richard Choo, M.D., Mayo Clinic:

Primary Outcome Measures:
  • Late grade ≥ 3 Gastrointestinal (GI) and Genitourinary (GU) toxicity of interest, using the CTCAE v4.0 [ Time Frame: 24 months post proton beam therapy ]

Secondary Outcome Measures:
  • Late grade ≥ 2 GI and GU toxicity of interest, using the CTCAE v4.0 [ Time Frame: 24 months post proton beam therapy ]
  • Acute grade ≥ 3 GI and GU toxicity of interest, using the CTCAE v4.0 [ Time Frame: Within 3 months post proton beam therapy ]
  • Disease-free survival including freedom from PSA relapse [ Time Frame: 5 years post proton beam therapy ]
  • Disease-specific survival [ Time Frame: 5 years post proton beam therapy ]

Estimated Enrollment: 51
Study Start Date: July 2016
Estimated Study Completion Date: August 2021
Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hypofractionation Proton beam therapy
Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes
Radiation: Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes

Detailed Description:

Proton beam therapy can provide a therapeutic gain by offering at least equivalent (or superior) tumor control while reducing the risk of radiation toxicity, in comparison with conventional photon-based external beam radiotherapy, given its dose-deposition characteristics. Currently the clinical target volume of proton beam for the treatment of prostate cancer has been mostly limited to the prostate and the seminal vesicles. There has been no study of proton beam therapy to treat both the primary tumor in the prostate and the regional pelvic nodes simultaneously using a moderate hypofractionation regimen.

The study is a prospective, single-arm, clinical trial to evaluate a moderate hypofractionation regimen of proton beam therapy for high risk or unfavorable intermediate risk prostate cancer. The clinical target volumes of proton beam therapy include both the prostate/seminal vesicles and the regional pelvic nodes. The primary objective is to assess late grade ≥ 3 gastrointestinal (GI) and genitourinary (GU) toxicity. The secondary objectives are to evaluate late grade ≥ 2 GI and GU toxicity, acute grade ≥ 3 GI and GU toxicity, and disease-free survival including freedom from PSA (prostate specific antigen) relapse at 5 years. The study provides an avenue to examine the safety, efficacy, cost effectiveness, and convenience of a moderate hypofractionation regimen (5-week course) of proton beam therapy.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male; Age ≥ 18 years.
  • Histological confirmation of adenocarcinoma of the prostate within 6 months of study enrollment.
  • Clinical stage T1-2 N0 M0, Gleason Score 7, Prostate Specific Antigen (PSA) 20-100 ng/mL, or Clinical stage Any T N0 M0, Gleason Score 8-10, PSA ≤ 100 ng/mL, or Clinical stage T3-4 N0 M0, any Gleason Score, PSA ≤ 100 ng/mL, or Clinical stage T1-2 N0 M0, Gleason Score 4+3, PSA 10-20 ng/mL
  • Zubrod performance score (PS) ≤ 1
  • Total bilirubin, aspartate aminotransferase, alkaline phosphatase, and serum creatinine: < 2 x upper normal limit
  • Signed informed consent.

Exclusion Criteria:

  • Any known nodal (N1) or distant metastasis (M1)
  • Previous androgen deprivation therapy lasting more than 6 months
  • History of inflammatory bowel disease
  • Presence of a hip prosthesis
  • Prior pelvic radiotherapy or prostatectomy
  • Prior or concurrent antineoplastic agents (chemotherapy)
  • Previous or concurrent malignancy other than non-melanoma skin cancer within 5 years of diagnosis of prostate cancer.
  • Inability to start the protocol treatment within 1 month after study enrollment.
  • Medical or psychiatric conditions that preclude informed decision-making or compliance with the protocol treatment or follow-up
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02874014


Contacts
Contact: Clinical Trials Referral Office 855-776-0015
Contact: Adam Amundson amundson.adam1@mayo.edu

Locations
United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Richard Choo, MD Mayo Clinic
  More Information

Responsible Party: Chunhee Richard Choo, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02874014     History of Changes
Other Study ID Numbers: 15-009528
First Submitted: August 17, 2016
First Posted: August 22, 2016
Last Update Posted: May 24, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases